Melanoma study to be conducted across Australia

Prima BioMed (ASX:PRR) has announced the Gallipoli Medical Research Foundation as the first clinical trial site for TACTI-mel, a Phase I study into melanoma treatment with lead compound IMP321. The study will evaluate safety as the primary endpoint, while  antitumour activity and the immune response will be the secondary endpoints.

Evidence has suggested that IMP321 can treat cancer by activating antigen-presenting cells (APC) to sustain an anticancer immune response, harnessing the patient’s own immune system to respond to tumour antigenic debris created by chemotherapy. This is a markedly different mechanism of action from checkpoint inhibitors and suggests that the two approaches can be used in combination, thus increasing the clinical and commercial potential of the activator.

The multicentre, open-label study will see patients with unresectable or metastatic melanoma dosed with IMP321 in combination with an approved inhibitor. According to principal investigator Dr Victoria Atkinson, it will be “the first human study combining IMP321 as an antigen-presenting cell activator together with a PD-1 checkpoint inhibitor”.

The Gallipoli Medical Research Foundation, based at Queensland’s Greenslopes Private Hospital, has been approved by the TGA to be the first of six sites to take part in the trial. Up to 24 patients will be recruited across the six sites, the first of which are expected to be dosed in the first quarter of 2016.

Prima BioMed (ASX:PRR) shares were trading 2.08% higher at $0.049 as of around 1 pm on Wednesday.